Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials Not Allowed)

The U.S. Department of Health and Human Services, through the National Institutes of Health and the National Institute on Drug Abuse, has released a Notice of Funding Opportunity titled “Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 – Clinical Trials Not Allowed).” This funding opportunity is designed to support the establishment of a specialized Center that will provide the infrastructure and expertise needed to accelerate drug development for substance use disorders through repurposing and repositioning of existing compounds. The initiative recognizes that although repurposed and repositioned drugs have potential to reduce costs and development time compared to traditional discovery, investigators in academia and small biotech often lack the expertise and resources to advance such projects to clinical and commercial stages. The Center’s mission is to serve academic and biotech investigators by offering expert guidance, resources, and tailored support across all stages of product development. It will provide services such as assay validation, preclinical development planning, clinical protocol design, regulatory pathway navigation, intellectual property analysis, and market access strategy development. Additionally, the Center will actively recruit projects from the research community, implement transparent evaluation criteria, and engage patients and communities affected by substance use disorders to ensure that research priorities reflect real-world needs. The structure of the Center will include five required cores: an Administrative Core to oversee operations, a Translational Support Core to provide scientific and methodological expertise, a Patient Engagement Core to ensure patient priorities are integrated, a User Project Sourcing and Assessment Core to identify and evaluate candidate projects, and a Freedom to Operate, Intellectual Property Strategy, and Market Access Core to address legal and commercial challenges. Together, these cores will provide comprehensive support for advancing investigator-driven projects in drug repurposing and repositioning for SUDs. Funding will be made through the cooperative agreement mechanism, reflecting a high level of federal involvement and collaboration with the NIH. NIDA intends to commit $2.5 million in fiscal year 2026 to support one award under this program. The award project period may not exceed five years, and budgets are not capped but must reflect the true needs of the proposed work. No clinical trials are allowed under this announcement, though applicants may propose activities that prepare for clinical development. Eligibility for this opportunity is broad and includes higher education institutions (both public and private), nonprofits, for-profit organizations, state and local governments, tribal governments, federal agencies, independent school districts, housing authorities, community-based organizations, regional organizations, and foreign entities. Both U.S. and non-U.S. organizations are eligible, as are foreign components of U.S. institutions. Cost sharing is not required. Applicants must ensure compliance with all NIH registration requirements, including active registration in SAM.gov, Grants.gov, eRA Commons, and related systems, which can take several weeks to complete. The funding announcement was posted on September 24, 2025, with the application open date set for December 28, 2025. Applications are due January 28, 2026, at 5:00 PM local time of the applicant organization. Applications will undergo peer review in July 2026, followed by Advisory Council review in August 2026, with earliest awards anticipated in September 2026. No late submissions will be accepted, and no letters of intent are required. The expiration date for this NOFO is January 29, 2026. Applicants will be evaluated according to NIH peer review criteria, including significance, investigator qualifications, innovation, approach, and environment. Special considerations for NIDA awards will apply. Applications that focus solely on alcohol use disorder, pain, or include clinical trials will not be reviewed. Questions related to scientific scope should be directed to Dr. Elena Koustova, Director of the Office of Translational Initiatives and Program Innovations at NIDA, via email at elena.koustova@nih.gov or phone at 301-496-8768. Financial and grants management inquiries may be sent to the Chief Grants Management Officer at NIDA via nidagmbemail@nida.nih.gov. Applicants are strongly encouraged to submit early to avoid errors and delays in the electronic submission process.

Submit early to allow time for error correction; ensure compliance with NIH Data Management and Sharing Plan; applications not conforming to requirements will not be reviewed; avoid non-responsive proposals such as alcohol-only, pain-only, or clinical trial submissions